Deputy QPPV Knowledge Assessment

To provide a concise, current prioritisation of issues requiring rapid attention during a handover To replace formal signal assessments and aggregate reports To document only completed activities for annual appraisal To determine the organisation's sales priorities

The Pharmacovigilance System Master File The product packaging artwork The commercial sales forecast The medical information call script

A verbal assurance that access will be granted if needed An access matrix, appropriate permissions, periodic testing and retained evidence such as logs or screenshots A shared generic password held by the whole PV department Access only to email, with no safety database or submission capability

The Deputy's name appears on an internal contact list The Deputy has defined authority, functional system access and a documented right to escalate safety concerns The Deputy receives copies of all company newsletters The Deputy is invited to commercial strategy meetings

Reviewing safety issues periodically, participating in governance and conducting targeted quality deep-dives Being listed as an emergency contact but receiving no PV information Attending only meetings unrelated to product safety Waiting for an inspector to request evidence of involvement

Activation whenever the Deputy believes it might be useful, without notification Activation based on objective triggers such as prolonged absence, hospitalisation or an urgent regulatory inquiry Activation only after an inspection has formally started Activation only when a product is withdrawn

To erase records created during the Deputy's activation To transfer documented status, decisions, submissions, open issues and actions back to the QPPV To allow the Deputy to retain all authority indefinitely To avoid reviewing actions taken during the absence

Percentage of company employees completing general compliance training Time taken to activate the Deputy after a defined trigger Number of products in the commercial portfolio Number of governance meetings attended by marketing

It replaces the need for the Deputy to be trained It enables rapid familiarisation with safety issues, responsibilities, systems and regulatory deadlines It serves only as a historical archive after an inspection It limits the Deputy's involvement to administrative matters

The number of versions of the delegation log retained The percentage of governance meetings scheduled in the calendar Compliance with expedited reporting timelines during the absence The number of people listed in the contact directory